MAUDE Adverse Event Report: ARTHROCARE CORPORATION MAGNUM 2 KNOTLESS IMPLANT; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number OM-1502

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that during a post operative visit following a shoulder procedure using a magnum 2 knotless implant, the x-ray showed the implant had backed up to the level of the cortical shelf.The surgeon feels that a revision surgery is unnecessary as the implant is still in the bone and the patient has not experienced any pain or complications at this time.

Manufacturer Narrative

The reported was not returned for evaluation, therefore the complaint could not be verified, nor could a root cause be determined with confidence.A potential root cause for the reported event could be attributable to incorrect insertion depth.Inserting the anchor to an incorrect depth (sub-cortical) can result in implant pull out or wing separation.Ifu states: -pathologic conditions of bone, such as cystic changes or severe osteopenia, which would impair its ability to securely fix the implant.-pathological changes in the soft tissues sutured to the bone, which would prevent its secure fixation by the suture.-a surgeon should not begin clinical use of the device without reviewing the instructions for use and practicing the procedure in a skills laboratory.-caution: use only 3.2 mm drill bit om-9010 or bone punch om-9020.Use of other drill bits or punches will compromise implant retention integrity.-warning: use care to properly align the implant and inserter handle with the bone hole while inserting the implant into the bone hole.Do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.Do not deploy a bent or damaged implant.-warning: incomplete insertion or poor bone quality may result in implant pullout.

• Brand Name: MAGNUM 2 KNOTLESS IMPLANT
• Type of Device: FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4804541
• MDR Text Key: 21545813
• Report Number: 3006524618-2015-00087
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OM-1502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR